Global PV QA Auditor — Drive Compliance & Risk

HC1316 GE Precision Healthcare LLC; United States; Remote; USD 102,000 - 153,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Paid time off

401(k) plan with company contribution

Job summary

GE HealthCare is seeking a QA Auditor for Pharmaceutical Diagnostics with a focus on PV QA and global compliance support to GMP manufacturing sites. The role emphasizes audits, regulatory liaison, risk analysis, and continuous improvement within the QA framework.

The candidate will monitor regulatory changes and guide updates to procedures and change controls, contributing to CAPA and QMS enhancements across PV-related functions.

Qualifications

• Bachelor's degree or 8+ years in pharmaceutical industry with high school credential
• 6+ years of pharmaceutical industry experience
• Previous auditing experience required
• Experience interfacing with global regulatory agencies
• Knowledge of GPvP, cGMP, and GDP

Responsibilities

• Support internal and external audits for QRA
• Ensure corrective actions are remediated and reviews completed
• Conduct risk analysis of systems and processes to propose audits
• Support regulatory inspections and customer audits as QA SME
• Perform trend analysis of audit data for stakeholders
• Oversee vendor qualification and surveillance activities
• Contribute to QMS improvements and CAPA guidance
• Provide QA approvals of Quality Event records
• Stay updated with MHRA, FDA, EMEA regulations and guidance

Skills

Auditing experience

Regulatory knowledge

Communication skills

Education

Bachelor's degree

High school diploma with 8+ years pharma experience

Job description

GE HealthCare is seeking a QA Auditor for Pharmaceutical Diagnostics with a focus on PV QA and global compliance support to GMP manufacturing sites. The role emphasizes audits, regulatory liaison, risk analysis, and continuous improvement within the QA framework.

The candidate will monitor regulatory changes and guide updates to procedures and change controls, contributing to CAPA and QMS enhancements across PV-related functions.